GI Organ Tracking Via Balloon Applicators

NCT ID: NCT05471401

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-25

Study Completion Date

2025-05-31

Brief Summary

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The hypothesis of this study is that an occlusion balloon catheter placed in the stomach via an oral or nasogastric route will be safe and permit tracking of the stomach during radiation therapy.

Detailed Description

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Conditions

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Esophageal Cancer Kidney Cancer Larynx Cancer Liver Cancer Lung Cancer Digestive Organs--Cancer Intrathoracic--Cancer Respiratory Organs--Cancer Pancreas Cancer Small Intestine Cancer Stomach Cancer Colon Cancer Rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Occlusion balloon catheter

-Each participant will have an embolectomy balloon that is FDA approved for peripheral and neurovasculature temporary occlusion placed by nose or mouth. Anatomical position of balloon will be verified by on-board MR or CT imaging in to assess feasibility of using a duodenal balloon in this population. Participants who are imaged on the MR treatment machine will also be imaged with 4 or 8 frame per second sagittal imaging to assess real-time stomach and balloon respiratory motion. Participants imaged on CT based imaging (i.e. Ethos/Halcyon ring gantry system) will have CBCTs acquired at timed intervals (approximately 5-10 minutes between scans). After imaging, the balloon will be deflated and removed at that time.

Group Type EXPERIMENTAL

Balloon-tipped catheter

Intervention Type DEVICE

Gastric balloon

Interventions

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Balloon-tipped catheter

Gastric balloon

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Scheduled to receive intra-thoracic or abdominal radiation therapy. It is not required that the stomach be in the radiation field.
* At least 18 years of age.
* ECOG performance status ≤ 1
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria

* Prior trauma or surgical intervention that would alter the anatomy of the upper airs (nasogastric route), esophagus or stomach.
* Previous complete or partial surgical resection of the esophagus, stomach, or duodenum.
* Presence of implantable devices (e.g., automatic internal cardiac defibrillator, cardiac or gastric pacemaker).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hyun Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Related Links

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http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

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202207133

Identifier Type: -

Identifier Source: org_study_id

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